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INDEX:
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Effective Date: 07/11/2013 Title: HDC & Autologous Stem and/or Progenitor Cell Support - Non-Hodgkin`s Lymphomas
Revision Date: Document: BI415:00
CPT Code(s): 38230, 38240-38242
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

High Dose Chemotherapy and stem cell transplant requires pre-authorization.

Autologous stem cell transplants are covered for selected patients with non Hodgkin’s lymphoma.


Medical Statement

High dose chemotherapy with autologous bone marrow, stem cell or progenitor cell support for treatment of non-Hodgkin`s lymphoma (NHL) is considered medically necessary and is covered:

 

International Working Formulation (IWF) subtypes intermediate or aggressive:

    • as salvage therapy for patients who do not achieve a complete remission (CR) after first-line treatment (induction) with a full course of standard-dose chemotherapy;
    • to consolidate a first complete response for patients with an age-adjusted International Prognostic Index score that predicts a high- or high-intermediate risk of relapse; and
    • to achieve or consolidate CR for those in a chemosensitive first or subsequent relapse.

For patients with NHL subtypes the IWF scheme classified as indolent, and for new subtypes defined by the World Health Organization/Revised European American Lymphoma scheme

    • as salvage therapy for patients who do not achieve a complete remission (CR) after first-line treatment (induction) with a full course of standard-dose chemotherapy;
    • to achieve or consolidate CR for those in a first or subsequent chemosensitive relapse, whether or not their lymphoma has undergone transformation to a higher grade.

 

Codes Used In This BI:

38230, Bone marrow harvesting for transplantation

38240, Bone marrow or blood-derived peripheral stem cell transplantation; allogenic

38241, Bone marrow or blood-derived peripheral stem cell transplantation; autologous

38242, Bone marrow or blood-derived peripheral stem cell transplantation; allogeneic donor lymphocyte infusions


Limits

High dose chemotherapy with allogeneic stem and/or progenitor cell support is not covered following autologous stem and/or progenitor cell transplantation.

Tandem high dose chemotherapy with autologous stem and/or progenitor cell support is not covered for any diseases other than multiple myeloma and Waldenstrom’s macroglobulinemia.

A second or subsequent course of high dose chemotherapy with allogeneic or autologous stem cell and/or progenitor cell support for treatment of relapsed disease is covered only for patients who have shown a complete response to the initial high dose chemotherapy/transplant regimen.

Coverage of high dose chemotherapy with allogeneic or autologous stem and/or progenitor cell support for a patient with two active malignant diseases is covered only if both diseases have a specific coverage policy and the patient meets all criteria for both high dose chemotherapy with stem and/or progenitor cell treatment regimens.


Background
The available evidence suggested that, based on total tumor response rates and complete response rates in patients with intermediate or high-grade lymphomas, the use of HDC with autologous stem-cell support produced outcomes comparable to salvage therapy for intermediate- and high-grade lymphomas. The rationale for HDC and allogeneic stem-cell support in intermediate or high-grade lymphomas was based on the success seen with HDC and autologous stem-cell support, where the estimated 3- to 5-year survival was 40%–60%. However, some patients were not candidates for autologous stem-cell support due to chronic marrow hypocellularity or malignancy involving the bone marrow. Allogeneic stem-cell support provided an alternative. The data suggested that the 3- to 5-year survival rates associated with allogeneic stem-cell support were comparable to those associated with autologous stem-cell support. o Data were minimal concerning outcomes of allogeneic stem-cell support, and most reports focused on outcomes of HDC without regard to the source of stem cells. Thus, the literature reviewed only compared outcomes after HDC supported by any source of stem cells to outcomes after conventional-dose regimens. Whether there was a treatment advantage for allogeneic or autologous stem-cell support was unknown. o Data were inadequate to compare outcomes of high-dose therapy plus either allogeneic or autologous stem-cell support with conventional-dose alternatives for patients with low-grade or follicular NHL either as primary therapy or as salvage therapy after relapse and transformation to a higher grade NHL histology. Sufficient data were reported to assess outcomes of HDC as salvage therapy for low-grade follicular lymphoma that had failed primary treatment without transformation to a higher grade. In this group of patients, the disease-free survival at 5 years was 10%–66% after HDC and only 2%–21% after conventional-dose alternatives. Given the natural history of this indolent disease, which is one of repeated relapses and progressively shorter durations of remission, improvement in disease-free survival was considered a good predictor of improvement in overall survival.
Reference

1987 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; p 61.

1990 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; p 178.

1995 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 28.

2000 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 9.

Apostolidis J, Foran JM, Johnson PW, et al.(1999) Patterns of outcome following recurrence after myeloablative therapy with autologous bone marrow transplantation for follicular lymphoma. J Clin 1999 Oncol; 17(1):216-21.

Ballestrero A, Clavio M, Ferrando F, et al.(2000) High-dose chemotherapy with tandem autologous transplantation as part of the initial therapy for aggressive non-Hodgkin’s lymphoma. Int J Oncol 2000; 17(5):1007-13.

Berglund A, Enblad G, Carlson K, et al.(2000) Long-term follow-up of autologous stem-cell transplantation for follicular and transformed follicular lymphoma. Eur J Haematol 2000; 65(1):17-22.

Bierman PJ, Vose JM, Anderson JR, et al.(1997) High-dose therapy with autologous hematopoietic rescue for follicular low-grade non-Hodgkin’s lymphoma. J Clin Oncol 1997; 15(2):445-50.

Blay JY, Philip TO.(1996) High-dose chemotherapy in non-Hodgkin’s lymphoma. Cancer Treat Res 1996; 85:87-103.

Blystad AK, Enblad G, Kvaloy S, et al.(2001) High-dose therapy with autologous stem cell transplantation in patients with peripheral T-cell lymphomas. BMT 2001; 27(7):711-16.

Bolwell B, Kalaycio M, Andresen S, et al.(2000) Autologous peripheral blood progenitor cell transplantation for transformed diffuse large-cell lymphoma. Clin Lymphoma 2000; 1(3):226-31; discussion 232-3.

Brandt L, Kimby E, Nygren P, et al.(2001) A systematic overview of chemotherapy effects in indolent non-Hodgkin’s lymphoma. Acta Oncol 2001; 40(2-3):213-23.

Chen CI, Crump M, Tsang R, et al.(2001) Autotransplants for histologically transformed follicular non-Hodgkin’s lymphoma. Br J Haematol 2001; 113(1):202-8.

Decaudin D, Brousse N, Brice P, et al.(2000) Efficacy of autologous stem cell transplantation in mantle cell lymphoma: a 3-year follow-up study. BMT 2000; 25(3):251-6.

Fisher RI.(2001) Autologous bone marrow transplantation for aggressive non-Hodgkin’s lymphoma: lessons learned and challenges remaining. J Natl Cancer Inst 2001; 93(1):4-5.
Fisher RI.(2002) Autologous stem-cell transplantation as a component of initial treatment for poor risk patients with aggressive non-Hodgkin’s lymphoma: resolved issues versus remaining opportunity. J Clin Oncol 2002; 20(22):4411-2.

Foran JM, Apostolidis J, Papamichael D, et al.(1998) High-dose therapy with autologous hematopoietic support in patients with transformed follicular lymphoma: a study of 27 patients from a single centre. Ann Oncol 1998; 9(8):865-9.

Freedman AS, Gribben JG, Nadler LM.(1998) High dose therapy and autologous stem cell transplantation in follicular non-Hodgkin’s lymphoma. Leuk Lymphoma 1998; 28(3-4):219-30.

Friedberg JW, Neuberg D, Gribben JG, et al.(1999) Autologous bone marrow transplantation after histologic transformation of indolent B cell malignancies. Biol Blood Marrow Transplant 1999; 5(4):262-8.

Hahn T, Wolff SN, Czuczman M, et al.(2001) The role of cytotoxic therapy with hematopoietic stem cell transplantation in the therapy of diffuse large cell B-cell non-Hodgkin’s lymphoma: an evidence-based review. Biol Blood Marrow Transplant 2001; 7(6):308-31.

Haioun C, Lepage E, Gisselbrecht C, et al.(1997) Benefit of autologous bone marrow transplantation over sequential chemotherapy in poor-risk aggressive non-Hodgkin’s lymphoma: updated results of the prospective study LNH87-2. Groupe d’Etude des Lymphomes de l’Adulte. J Clin Oncol 1997; 15(3):1131-7.

Haioun C, Lepage E, Gisselbrecht C, et al.(2000) Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin’s lymphoma: final analysis of the prospective LNH87-2 protocol--a Groupe d’Etude des Lymphomes de l’Adulte study. J Clin Oncol 2000; 18(16):3025-30.

Haioun C, Mounier N, Quesnel B, et al.(2001) Tandem autotransplants as first-line consolidative treatment in poor-risk aggressive lymphoma: a pilot study of 36 patients. Ann Oncol 2001; 12(12):1749-55.

Kaiser U, Uebelacker I, Abel U, et al.(2002) Randomized study to evaluate the use of high-dose therapy as part of primary treatment for “aggressive” lymphoma. J Clin Oncol 2002; 20(22):4413-9.

Kimby E, Brandt L, Nygren P, et al.(2001) A systematic overview of chemotherapy effects in aggressive non-Hodgkin’s lymphoma. Acta Oncol 2001; 40(2-3):198-212.

Kluin-Nelemans HC, Zagonel V, Anastasopoulou A, et al.(2001) Standard chemotherapy with or without high-dose chemotherapy for aggressive non-Hodgkin’s lymphoma: randomized phase III EORTC study. J Natl Cancer Inst 2001; 93(1):22-30 (also see comment, pp 4-5).
Martinez C, Carreras E, Rovira M, et al.(2000) Patients with mantle-cell lymphoma relapsing after autologous stem cell transplantation may be rescued by allogeneic transplantation. BMT 2000; 26(6):677-9.

Morrison VA, Peterson BA.(1999) High-dose therapy and transplantation in non-Hodgkin’s lymphoma. Semin Oncol 1999; 26(1):84-98.

Mounier N, Haioun C, Cole BF, et al.(2000) Quality of life-adjusted survival analysis of high-dose therapy with autologous bone marrow transplantation versus sequential chemotherapy for patients with aggressive lymphoma in first complete remission. Groupe d’Etude les Lymphomes de l’Adulte (GELA). Blood 2000; 95(12):3687-92.

Nagler A, Slavin S, Varadi G, et al.(2000) Allogeneic peripheral blood stem cell transplantation using a fludarabine based low intensity conditioning regimen for malignant lymphoma. BMT 2000; 25(10):1021-8.

Papadopoulos KP, Noguera-Irizarry W, Hesdorffer CS.(2001) Tandem transplantation in lymphoma. BMT 2001; 28(6):529-35.

Philip T, Biron P.(2002) High-dose chemotherapy and autologous bone marrow transplantation in diffuse intermediate- and high-grade non-Hodgkin lymphoma. Crit Rev Oncol Hematol 2002; 41(2):213-23.

Rodriguez J, Munsell M, Yazji S, et al.(2001) Impact of high-dose chemotherapy on peripheral T-cell lymphomas. J Clin Oncol 2001; 19(17):3766-70.

Siegert W, Rick O, Beyer J.(1998) High-dose chemotherapy with autologous stem cell support in poor-risk germ cell tumors. Ann Hematol 1998; 76:183-8.

Sweetenham JW, Santini G, Qian W, et al.(2001) High-dose therapy and autologous stem-cell transplantation versus conventional-dose consolidation/maintenance therapy as postremission therapy for adult patients with lymphoblastic lymphoma. J Clin Oncol 2001; 19(11):2927-36.

Sweetenham JW.(2001) Stem cell transplantation for mantle cell lymphoma: should it ever be used outside clinical trials. BMT 2001; 28(9):813-20.

The Non-Hodgkin’s Lymphoma Classification Project.(1997) A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin’s lymphoma. Blood 1997; 89(11):3909-18.

Vose JM, Bierman PJ, Lynch JC, et al.(1998) Effect of follicularity on autologous transplantation for large-cell non-Hodgkin’s lymphoma. J Clin Oncol 1998; 16(3):844-9.

Vose JM, Bierman PJ, Weisenberger DD, et al.(2000) Autologous hematopoietic stem cell transplantation for mantle cell lymphoma. Biol Blood Marrow Transplant 2000; 6(6):640-5.

Williams CD, Harrison CN, Lister TA, et al.(2001) High-dose therapy and autologous stem-cell support for chemosensitive transformed low-grade follicular non-Hodgkin’s lymphoma: a case-matched study from the European Bone Marrow Transplant Registry. J Clin Oncol 2001; 19(3):727-35.

Williams CD, Taghipour G, Lister TA, et al.(1996) Chemosensitive transformed follicular non Hodgkin`s lymphoma (NHL) is a firm indication for high dose therapy and autologous stem cell transplantation. Blood 1996; 87:685a.

Williams CD, Taghipour G, Lister TA, et al.(1996) Chemosensitive transformed follicular nonHodgkin’s lymphoma (NHL) is a firm indication for high-dose therapy and autologous stem cell transplantation. Blood 1996; 87(sup 1):685a.

 


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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